It is absurd from the FDA’s end to impose a level that is untested, especially when such level is not controllable as it varies according to conditions such weather and humidity levels.

Public Health Expert Clive Bates is calling the proposed regulation reckless and pointless, while the Scientific Director of CASAA Carl V. Phillips, is calling the FDA’s arguments in favour of this regulation innumerate and junk science. Bates pointed out that he is generally in favour of regulations and standards, as they promote transparency and consistency, however, he added, there are “three qualifiers to this cheery endorsement of standards”. A standard has to serve a purpose, it has to be achievable and it’s consequences should not outweigh its benefits.

This proposed regulation, “fails all of the above” stated Bates. The first point to take in consideration is that the FDA’s proposed standard of NNN is set at the lower extremity of what is available on the market. Bates pointed out that it is absurd from the FDA’s end to impose a level that is untested, especially when in the case of NNN the level is not controllable as it varies according to conditions such as the weather and humidity levels.

“So a hardly-used ‘dirty product’ was added to the mix to beef up the risk estimates, which were then applied to the widely-used but much lower risk products such as American moist snuff.”Clive Bates, The Counterfactual

Additionally, added Bates, ‘dry snuff’ was included in the risk calculation, and this particular tobacco product is known for its elevated oral cancer risk. However, the market share of dry snuff is only 0.7%, hence it is rarely used. “So a hardly-used ‘dirty product’ was added to the mix to beef up the risk estimates, which were then applied to the widely-used but much lower risk products such as American moist snuff. Sleight of hand? I couldn’t possibly comment.“ pointed out Bates.

Submission to the FDA

Clive Bates together with lawyer and fellow public health advocate David Sweanor, submitted a letter to the FDA highlighting all the above in much further detail. Below is a summary :

Request. We respectfully suggest that the proposed rule is withdrawn as soon as possible after the closure of the comment process. Instead of pursuing damaging interventions on the lowest-risk tobacco products, FDA should redeploy its resources to encourage and facilitate smokers to switch to low-risk alternatives to cigarettes such as smokeless tobacco, heated tobacco products and vapor technologies.

The reasoning underpinning our suggestion is in four parts:

Overstates benefits. The benefits of the rule are overstated because the risk, and hence risk reduction, are overstated. This arises as a result of inappropriate pooling of relative risk estimates for different types of smokeless tobacco, some of which are more harmful but rarely used.

Understates disruption. The FDA analysis is based on a completely unrealistic excessively optimistic assessment of the achievability of the standard for the products that dominate the US market. The analysis assumes unrealistically high compliance at baseline, though this conflicts with measurement data presented in the draft rule. The disruption of the smokeless market will therefore be much greater than FDA claims. That will make compliance more expensive, cause exit of firms and products, and affect the character of products with which smokeless tobacco users are familiar.

Ignores unintended consequences. If consumers’ familiar products change in character, availability or price as a result of supply-chain disruption, it is not safe to assume that they will simply use these or other compliant smokeless products. The analysis is extremely sensitive to any additional smoking among the behavioral responses of smokeless tobacco users to supply chain disruption.

Fails tests for public health and good regulation. The proposed rule does not conform to the main principles of good regulation for federal agencies, and FDA has not shown that its rule would meet the public health test required for standard-setting under the Tobacco Control Act s907.

The proposed regulation considered a farce

“I am not being hyperbolic when I say FDA’s proposed rule comes across as parody,“ said Carl V Phillips on concluding an article about the topic on his blog. “Please reassure us, FDA, that this was intentional. Even more so, those of you at the Center for Tobacco Products might want to reassure your colleagues elsewhere in FDA that this is not what their once respectable agency has come to.”